Diabetes MellitusNCT02040025
Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Defense type 2 diabetic patients enrolled in the Travis AFB, CA EECP clinic.
Who may be able to join
- Age equal to or greater than 18
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Prescribed EECP therapy in the DGMC EECP clinic
- Medically cleared for EECP therapy
- TRICARE beneficiary
Who cannot join
- 1. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant USAF Medical Center
Travis Air Force Base, California, 94535
About this study
The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.
- Conditions
- Diabetes Mellitus
- Keywords
- hypertension, diabetes mellitus, hemoglobin A1C, peripheral vascular resistance, EECP, Blood pressure, angiogenesis, Coronary Artery Disease, Coronary Disease, Heart Diseases, Cardiovascular Diseases
- Medical subject headings
- Diabetes Mellitus, Hypertension, Coronary Artery Disease, Coronary Disease, Heart Diseases, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in TCOM (Transcutaneous oximetry measurement) values
Measured: At baseline & post intervention, expected to be on average 30 minutes
Secondary outcomes (1)
Change from baseline in hemoglobin A1C laboratory values
Measured: At baseline & post intervention, expected to be on average 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bradley Williams, MD, Principal investigator, David Grant U.S. Air Force Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040025
- Sponsor's protocol ID
- FDG20140010H
- Status last verified
- Apr 2020
- First submitted
- 16 Jan 2014
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin JS, Beck DT, Aranda JM Jr, Braith RW. Enhanced external counterpulsation improves peripheral artery function and glucose tolerance in subjects with abnormal glucose tolerance. J Appl Physiol (1985). 2012 Mar;112(5):868-76. doi: 10.1152/japplphysiol.01336.2011. Epub 2011 Dec 22.
PubMed 22194326Bondesson SM, Edvinsson ML, Pettersson T, Edvinsson L. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatr Cardiol. 2011 Dec;8(4):215-23. doi: 10.3724/SP.J.1263.2011.00215.
PubMed 22783308Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
PubMed 20921442
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02040025
- Acronym / sponsor ID
- FDG20140010H
- Conditions
- Diabetes Mellitus
- Keywords
- hypertension, diabetes mellitus, hemoglobin A1C, peripheral vascular resistance, EECP, Blood pressure, angiogenesis, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Defense type 2 diabetic patients enrolled in the Travis AFB, CA EECP clinic.
Key inclusion criteria (5 listed)
- Age equal to or greater than 18
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Prescribed EECP therapy in the DGMC EECP clinic
- Medically cleared for EECP therapy
- TRICARE beneficiary
Key exclusion criteria (1 listed)
- 1. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in TCOM (Transcutaneous oximetry measurement) values
Time frame: At baseline & post intervention, expected to be on average 30 minutes
1 secondary outcome
Change from baseline in hemoglobin A1C laboratory values
Time frame: At baseline & post intervention, expected to be on average 30 minutes
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 22194326Martin JS, Beck DT, Aranda JM Jr, Braith RW. Enhanced external counterpulsation improves peripheral artery function and glucose tolerance in subjects with abnormal glucose tolerance. J Appl Physiol (1985). 2012 Mar;112(5):868-76. doi: 10.1152/japplphysiol.01336.2011. Epub 2011 Dec 22.
- Background: PubMed 22783308Bondesson SM, Edvinsson ML, Pettersson T, Edvinsson L. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatr Cardiol. 2011 Dec;8(4):215-23. doi: 10.3724/SP.J.1263.2011.00215.
- Background: PubMed 20921442Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Williams, MD principal investigator
David Grant U.S. Air Force Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in TCOM (Transcutaneous oximetry measurement) values (time frame: At baseline & post intervention, expected to be on average 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040025, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.